Erosion risks

• Competitor outcomes data shifting preference in key sub-populations
• Pricing pressure from hospital cost containment and tenders
• New entrants expanding choice and reducing perceived differentiation

Leading indicators

• U.S. and EU procedure share trends for major TAVR platforms
• Guideline positioning and pivotal trial readouts (Edwards and competitors)
• ASP/price realization commentary and gross margin trajectory

Counterarguments

• Hospitals can dual-source valves; switching is feasible with incremental training
• Clinical outcomes can trump incumbent brand if competitors show superior results

Erosion risks

• Standardization of training across vendors reducing differentiation
• Hospital staff turnover reducing accumulated know-how advantage

Leading indicators

• Number of active TAVR centers and center expansions
• Changes in field support intensity or staffing
• Competitor training/proctoring programs scaling

Counterarguments

• Structural heart teams already manage multiple device vendors; training may not be a binding constraint
• Procurement decisions can override clinician preference in cost-focused environments

Erosion risks

• Regulatory harmonization reducing differential burden
• Competitors achieving approvals faster via strong clinical execution

Leading indicators

• FDA/CE approvals and label expansions for competitors
• Warning letters, recalls, or quality-system findings in the category
• Time-to-approval trends for new TAVR platforms

Counterarguments

• Large incumbents (e.g., MDT, ABT, BSX) can also navigate regulatory hurdles effectively
• Regulation can slow innovation cycles for incumbents as much as challengers

Erosion risks

• Patent expirations and patent challenges
• Design-arounds reducing enforceability
• Costly litigation outcomes

Leading indicators

• Major patent litigation outcomes and settlements in structural heart
• Patent expiry schedule for key valve/delivery system families
• Competitor platform launches with similar performance claims

Counterarguments

• Medical device IP often narrows to specific claims; competitors can innovate around patents
• Regulatory and clinical evidence may matter more than IP in adoption

Erosion risks

• Competitors achieving comparable approvals with differentiated devices
• Adverse trial outcomes or slower-than-expected adoption
• Reimbursement or guideline constraints

Leading indicators

• FDA/CE approvals and label expansions in mitral/tricuspid categories
• Procedure volume trends for tricuspid replacement and repair
• Post-market safety signals and registry outcomes

Counterarguments

• Category is crowded; incumbents in mitral repair (notably ABT) have strong positions
• Physician preference may fragment across multiple approaches (repair vs replacement)

Erosion risks

• Brand spillover limited if outcomes differ materially by anatomy/indication
• Competitors with stronger clinical datasets in mitral repair

Leading indicators

• New randomized trial results for repair/replacement approaches
• Site adoption and training program expansion
• Share of voice in guidelines and major conferences

Counterarguments

• Adjacent-category entry does not guarantee share in novel markets
• Hospitals may prefer best-in-class devices even if from different vendors

Erosion risks

• Standardization of procedures and training across vendors
• Center learning curves shortening as the market matures

Leading indicators

• Number of implanting centers and physician training throughput
• Competitor proctoring/training scale and field footprint
• Turnover in structural heart program staffing

Counterarguments

• Experienced centers can onboard additional devices without major disruption
• Reimbursement and outcomes may dominate training friction in purchasing decisions

Erosion risks

• Long-term durability data for competitors narrowing perceived gap
• Shift of eligible patients from surgical to transcatheter approaches
• Hospital purchasing consolidation increasing price competition

Leading indicators

• Long-term durability outcomes published in peer-reviewed venues
• Surgical procedure volumes vs transcatheter substitution trends
• Competitive wins/losses in major health systems and buying groups

Counterarguments

• Surgical valve market includes large diversified competitors with deep relationships
• Durability claims can be matched over time as competitors accumulate data

Erosion risks

• Quality issues or recalls damaging reputation
• Regulatory changes increasing costs for all incumbents

Leading indicators

• Inspection outcomes, warning letters, recalls (company and category)
• Manufacturing yield and supply continuity commentary
• Regulatory policy changes affecting implantable devices

Counterarguments

• Large incumbents also meet these standards, limiting relative advantage
• Compliance is table-stakes; differentiation must come from outcomes and features

Erosion risks

• Supplier concentration leading to disruption risk
• Geopolitical/trade restrictions impacting inputs

Leading indicators

• Backorders or supply interruptions disclosed by the company
• Input cost inflation and tariff impacts
• Supplier diversification and qualification progress

Counterarguments

• Single-source constraints can be a vulnerability rather than a moat
• Major competitors have similarly mature supply chains